Device product
smith&nephew ANTHOLOGY POROUS HIGH OFFSET STEM, 12/14 TAPER, 7H SIZE, 32 MM x 112 MM, REF 71356107 Hip prosthesis.
Z-1921-2018
Product summary
- Event
- Event 80050
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 units
- Official record key
device-enforcement:Z-1921-2018
Official wording
Reason: Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.
Code information: Lot Numbers: 17LM22019, 17LM10934, 17LM05900
Distribution pattern: US nationwide distribution.
Derived failure modes
-
Unknown
Three lots of Anthology HO Porous size 7 stems were manufactured with an undersized taper length. The device taper length was incorrectly manufactured as 0.393mm opposed to 0.442 mm.